DIN EN ISO 22442-3:2008-03
Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007); German version EN ISO 22442-3:2007
| Fecha edición: |
2008-03-01
En Vigor
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|---|---|
| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This Part of ISO 22442 specifies requirements for the validation of the elimination and/or inactivation of viruses and TSE agents during the manufacture of medical devices (excluding in-vitro diagnostic medical devices) utilizing animal tissue or products derived from animal tissue, which are non-viable or have been rendered non-viable. It does not cover other transmissible and non-transmissible agents. |
| Keywords: | Agents|Analysis|Animal|Animal products|Animals|Applications|Auxiliary devices|Biological hazards|Calibration|Causative organisms|CE marking|Cell cultures|Checks|Collections|Concentration|Control charts|Data|Definitions|Derivatives|Elimination|Equipment|Exclusion|Experiences|Fabrics|Guide books|Gullies|Handling|Health hazards|Impurities|Inactive|Medical devices|Medical products|Medical sciences|Methods|Pathogenic bacteria|Personnel|Procedures|Process|Production|Risk|Risk analysis|Safety|Specification (approval)|Tissue|Training|TSE|Use|Validation|Viruses|Winning |
| ICS: | 11.100.99 - Otras normas relativas a medicina de laboratorio |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 22442-3:2007 Idéntica ISO 22442-3:2007 |
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Reemplazo Normas |
Reemplaza a DIN EN 12442-3:2001-01 Reemplaza a DIN EN ISO 22442-3:2006-09 |
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